MAUDE Adverse Event Report: GETINGE/MAQUET/DATASCOPE CORP. IABP CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 3000259390

Device Problems Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Arrhythmia (1721); Failure of Implant (1924)

Event Date 09/14/2022

Event Type  Injury  

Event Description

Intra-aortic balloon pump (iabp) suddenly showed alarm of optic sensor failure.Md was immediately called regarding the alarm.We followed the instructions the device provided to troubleshoot the issue, but the alarm continued.The device rep was called but was unable to resolve the issue.Throughout the rest of the shift, every pvc/pac beat the patient had on the bedside monitor, the iabp was unable to receive an appropriate trigger and the device would automatically default into "standby" mode, thus not supporting the patient.The patient was experiencing more ectopy thereafter and we had to manually restart the iabp every few seconds.During this time, the patient denied any pain/ discomfort.The patient was taken to the cath lab for replacement of the iabp catheter and the console was also changed out.Fda safety report id #(b)(4).

• Brand Name: IABP CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE/MAQUET/DATASCOPE CORP.; wayne NJ 07470
• MDR Report Key: 15445800
• MDR Text Key: 300277344
• Report Number: MW5112091
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3000259390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White